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NCT ID: NCT00835978 Active, not recruiting - Clinical trials for Carcinoma, Renal Cell

Axitinib (AG-013736) With Or Without Dose Titration (Increase) In Patients With Kidney Cancer

Start date: August 2009
Phase: Phase 2
Study type: Interventional

Axitinib dose titration (giving a higher dose of the drug above its standard starting dose) among certain patients may improve the response to treatment.

NCT ID: NCT00829166 Active, not recruiting - Breast Cancer Clinical Trials

An Open-label Study of Trastuzumab Emtansine (T-DM1) vs Capecitabine + Lapatinib in Patients With HER2-positive Locally Advanced or Metastatic Breast Cancer

EMILIA
Start date: February 2009
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomized, multicenter, international, 2-arm, open-label clinical trial designed to compare the safety and efficacy of trastuzumab emtansine (T-DM1) with that of capecitabine + lapatinib for HER2-positive metastatic breast cancer (MBC). Patients were treated until disease progression, unmanageable toxicity, or study termination. Once disease progression was reported, all patients were followed for survival every 3 months until death, loss to follow-up, withdrawal of consent, or study termination.

NCT ID: NCT00811135 Active, not recruiting - Breast Cancer Clinical Trials

A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab) and Xeloda (Capecitabine) in Patients With HER2-Positive Breast Cancer

Start date: December 2008
Phase: Phase 2
Study type: Interventional

This single arm study will assess the efficacy and safety of Avastin in combination with Herceptin and Xeloda as first-line treatment of patients with HER2-positive locally recurrent or metastatic breast cancer. Patients will receive 3-weekly treatment cycles of Herceptin (8mg/kg iv on day 1 of first cycle, followed by 6mg/kg iv maintenance dose on day 1 of subsequent cycles), Xeloda (1000mg/m2 bid po on days 1-14 of each treatment cycle) and Avastin (15mg/kg on day 2 of first treatment cycle,and on day 1 of each subsequent cycle).The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

NCT ID: NCT00777036 Active, not recruiting - Leukemia Clinical Trials

A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib

Start date: March 20, 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether dasatinib is safe and effective in children and adolescents with newly diagnosed chronic myeloid leukemia (CML), or in children with Ph+ acute lymphoblastic leukemia (ALL), accelerated or blast phases CML who relapse after imatinib or who are resistant or intolerant to imatinib. The side effects of this oral investigational drug in children and adolescents will be evaluated

NCT ID: NCT00718263 Active, not recruiting - Clinical trials for Myelogenous Leukemia, Chronic

Efficacy and Safety of Nilotinib Patients With Newly Diagnosed CML - CP (Chronic Myelogenous Leukemia - Chronic Phase)

PHCHBS-WD4070
Start date: April 2008
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and tolerability of nilotinib after failure of imatinib therapy or imatinib therapy after nilotinib failure.

NCT ID: NCT00715637 Active, not recruiting - Clinical trials for Secondary Acute Myeloid Leukemia (Secondary AML, sAML)

Phase III Randomized Study of Amonafide (AS1413) and Cytarabine Versus Daunorubicin and Cytarabine in Patients With Secondary Acute Myeloid Leukemia (AML)- the ACCEDE Study

Start date: June 2007
Phase: Phase 3
Study type: Interventional

Amonafide is a DNA intercalating agent and inhibitor of topoisomerase II that has been extensively studied in patients with malignant solid tumors. Amonafide has also been studied in patients with AML. The purpose of this study is to assess the relative efficacy and safety of amonafide in combination with cytarabine compared to daunorubicin with cytarabine in subjects with documented secondary AML.

NCT ID: NCT00680901 Active, not recruiting - Clinical trials for Neoplasms, Gastrointestinal Tract

LOGiC - Lapatinib Optimization Study in ErbB2 (HER2) Positive Gastric Cancer: A Phase III Global, Blinded Study Designed to Evaluate Clinical Endpoints and Safety of Chemotherapy Plus Lapatinib

Start date: June 4, 2008
Phase: Phase 3
Study type: Interventional

This is an international multi-center trial that will enroll patients with locally advanced, unresectable, or metastatic gastric, esophageal, or gastro-esophageal junction cancer whose tumors have amplification of the ErbB2 (HER2) gene. The trial will investigate whether lapatinib, when added to the chemotherapy regimen, capecitabine plus oxaliplatin (CapeOx), extends the time to progression and overall survival. Tumor ErbB2 (HER2) status must be known before trial entry. CapeOx is administered to all patients, and patients will be randomly assigned to receive either lapatinib or placebo.

NCT ID: NCT00622700 Active, not recruiting - Multiple Sclerosis Clinical Trials

Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis

TOPIC
Start date: February 2008
Phase: Phase 3
Study type: Interventional

The primary objective is to demonstrate the effect of teriflunomide (HMR1726) (14 milligram per day [mg/day] and 7 mg/day), in comparison to placebo, for reducing conversion of participants presenting with their first clinical episode consistent with multiple sclerosis (MS) to clinically definite multiple sclerosis (CDMS). The secondary objectives are: - To demonstrate the effect of teriflunomide, in comparison to placebo, on: - Reducing conversion to definite multiple sclerosis (DMS) - Reducing annualized relapse rate (ARR) - Reducing disease activity/progression as measured by Magnetic Resonance Imaging (MRI) - Reducing accumulation of disability for at least 12 weeks as measured by the Expanded Disability Status Scale (EDSS) - Proportion of disability-free participants as assessed by the EDSS - Reducing participant-reported fatigue - To evaluate the safety and tolerability of teriflunomide - To evaluate the pharmacokinetics (PK) of teriflunomide - Optional pharmacogenomic testing aimed at assessing the association between the main enzyme systems of teriflunomide metabolism and hepatic safety, and other potential associations between gene variations and clinical outcomes

NCT ID: NCT00600886 Active, not recruiting - Acromegaly Clinical Trials

Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly

Start date: February 2008
Phase: Phase 3
Study type: Interventional

The patients will receive either Pasireotide LAR or Octreotide LAR for one year of treatment. The objective of this study is to compare the proportion of patients with a reduction of mean GH level to <2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) between the two treatment groups (pasireotide LAR and octreotide LAR) at 12 months. Following one year of treatment patients may proceed into the study extension. Patients who did not respond to the treatment they were randomized to (based on month 12 assessment results) will be switched to the other treatment arm at month 13.

NCT ID: NCT00478946 Active, not recruiting - Colorectal Cancer Clinical Trials

A Study of Picoplatin in Colorectal Cancer

Start date: April 2006
Phase: Phase 1/Phase 2
Study type: Interventional

Colorectal cancer is a type of cancer that begins in the large intestine (colon) or the rectum (end of the colon). Several drugs are often given in combination to treat colorectal cancer. One of the most active treatment combinations is known as FOLFOX, which is a combination of 5-fluorouracil (5-FU), leucovorin, and oxaliplatin. Oxaliplatin is a type of platinum drug and was approved by the FDA in 2004. While generally well-tolerated, oxaliplatin may cause toxicity to the nerves, such as sensory loss or cold sensitivity. Picoplatin is a new type of platinum drug that has shown activity with 5-FU in pre-clinical studies and has undergone extensive Phase 1 and Phase 2 testing in a variety of cancers. No significant nerve toxicity has been seen in previous studies of picoplatin. This study will review the safety and effectiveness of FOLPI, which is the combination of 5-FU and leucovorin with picoplatin in participants with colorectal cancer.